The Recall Desk
ModerateFDA (Drugs)·D-0696-2022·Announced 2022-03-30

Triamcinolone Acetonide Ointment USP 0.5% Recalled by Teligent Pharma

Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.5% due to current good manufacturing practice (cGMP) deviations. The firm has discontinued its stability study program, affecting approximately 159,994 tubes distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text indicates cGMP deviations related to discontinuation of stability testing, which is a manufacturing/compliance issue. No illnesses, injuries, or product quality failures are reported in the source text, making this a precautionary recall based on process deficiency rather than demonstrated harm.

Plain-English summary

Teligent Pharma, Inc. is recalling Triamcinolone Acetonide Ointment USP, 0.5% (15 gram tubes, NDC 52565-048-15) due to cGMP deviations. All products within expiry date are included in the recall because the firm is discontinuing its stability study program.

The recalled product was distributed nationwide in the USA and Puerto Rico. Approximately 159,994 tubes are affected across three batches: Batch 15608 (Exp. 5/31/2022), Batch 16026 (Exp. 9/30/2022), and Batch 16224 (Exp. 11/30/2022).

Patients currently using this medication should contact their healthcare provider or pharmacist before discontinuing use. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program.

The recalled product

Product
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
159,994

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Batch: 15608
  • Exp. 5/31/2022
  • 16026
  • Exp. 9/30/2022
  • 16224
  • Exp. 11/30/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Related recalls

Same manufacturer · Teligent Pharma, Inc.

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Same hazard · cGMP deviation

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